Webinar Peptides with ISO 13485: Gold Standard for Medical Device Safety

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Webinar Peptides with ISO 13485: Gold Standard for Medical Device Safety

Peptides can be utilised as critical raw materials for in vitro diagnostics (IVD) to measure the presence or concentration of a biomarker molecule that indicates disease. Quality and safety are paramount in all aspects of the medical device industry, and it is crucial to have a reliable and trusted supplier of critical raw materials that can demonstrate the ability to implement robust manufacturing processes, provide full traceability and documentation, and adhere to industry standard change control practices.

Bachem’s Centre of Excellence for Research Chemicals in St. Helens, UK, has been ISO 13485 certified to manufacture peptides as critical raw materials for medical devices since 2017 and is perfectly placed to partner with you on your journey to the commercialisation of your peptide based IVD kits.

Join our webinar “Peptides with ISO 13485: Gold Standard for Medical Device Safety” to learn more about how we ensure that the peptides we manufacture for use in medical devices meet those stringent regulatory requirements.

About the Speakers

Iain Pritchard

Site Manager Bachem UK

After graduating from the University of Strathclyde with a BSc. in Forensic & Analytical Chemistry, Iain joined Bachem (UK) Ltd. in 2004 as a Chemist in the Manufacturing (Upstream) Group. He became Group Leader in 2006 and then Director of Production in 2013. Between 2006-2011, Iain completed his Ph.D. part time at Imperial College, London, studying the effects of Peptide YY analogues on appetite. ​​​​After 10 years as Director of Production, Iain was appointed Site Manager in July 2024 and now has more than 20 years experience of the manufacture of peptides for use in research and in-vitro diagnostics.

Joanne Capener

QMS Manager / H&S Adviser

With a career spanning three decades, Joanne has dedicated herself to the field of In Vitro Diagnostics (IVDs) in Cancer Diagnostics and Class Ila Medical Devices.
In 2020, Joanne joined Bachem (UK) Ltd, where she is now Group Leader of Quality Assurance (QA) and Health, Safety and Environment (HSE). Her responsibilities include ensuring that the company meet the highest standards of quality and safety, adhering to both ISO 13485 and current health and safety legislation. Joanne is a certified ISO 13485 Lead Auditor and also holds a NEBOSH qualification for health and safety.

Daniel Yasini

Sales Manager Custom Synthesis

Daniel graduated with a Master’s degree in Organic Chemistry from the University of Milan and spent 3 years in the process development of small molecule synthesis.
Since June 2024, Daniel has joined Bachem as Sales Manager for Custom Synthesis. He is responsible for small-scale, non-GMP peptide sales for Bachem UK, ensuring the highest industry standards are met.

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